About this opportunity:
At Freenome, we are seeking a Contract Clinical Research Associate to help grow the Freenome Clinical Development team. The ideal candidate is well-organized, an excellent communicator and experienced in supporting clinical trial execution for diagnostics products. This person is responsible for all things related to assigned aspects of clinical trial start-up and study progress including documentation collection and tracking. You are passionate about clinical research, attention to detail and Good Clinical Practice, and you will have a significant impact on the continued growth of an organization dedicated to changing the entire landscape of cancer.
The role reports to the Director of Clinical Operations. This role will be a Remote role with occasional travel, as required, to our Brisbane, California headquarters.
What you’ll do:
- Coordinate and assist with trial start-up activities, including budget and contract negotiations, ICF revisions, and essential document packages
- Coordinate and track study documentation and other functional activities that relate to the conduct of clinical trials
- Facilitate resolution of laboratory queries
- Track metrics and study start-up timelines to identify trends and opportunities for improvement
- Track and report on study progress, including site activation, patient enrollment, monitoring visits
- Ensure that all essential study documents are filed appropriately and kept in an organized central repository for the project team (Veeva Vault)
- Lead the management of the TMF, including establishing QC processes and reconciliation of findings
- Assist with protocol and study-specific training with vendors, site personnel, and clinical sites
- Support Clinical Trial Managers and Clinical Research Associates with vendor management activities
Must haves:
- Minimum Bachelor’s degree in a life science-related field
- 2+ years’ experience in a clinical trials research environment required, as a Clinical Trial Coordinator or Clinical Trial Assistant
- General knowledge of regulatory requirements & GCP
- Ability to multi-task, deal with shifting priorities, and proactively solve problems/manage risks
- Proficient in Microsoft Office or Google Suite
- Strong interpersonal, collaborative, and time management abilities
- Excellent attention to detail and the ability to keep detailed, accurate records
- High proficiency in Veeva Vault CTMS and eTMF systems
- Strong spoken and written communication skills
Nice to haves:
- Previous experience in the cancer early detection or diagnostics space
Additional information:
Contractors may be hired through a third-party provider and will be considered contingent workers. We invite you to check out our career page @ freenome.com/job-openings/ for additional company information.
Freenome is proud to be an equal opportunity employer and we value diversity. Freenome does not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.
Applicants have rights under Federal Employment Laws.
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